Breast Cancer Clinical Trial
Official title:
A Randomized Controlled Double-blinded Study Comparing the Intraoperative Injection of Lymphatic Mapping Agents Tc 99m Tilmanocept to Tc 99m Filtered Sulfur Colloid in Breast Cancer Patients Undergoing Breast Conservation and Sentinel Lymph Node Biopsy
A randomized controlled double-blinded study comparing the intraoperative injection of lymphatic mapping agents Tc 99m tilmanocept to Tc 99m filtered sulfur colloid in breast cancer patients undergoing breast conservation and sentinel lymph node biopsy
Status | Recruiting |
Enrollment | 86 |
Est. completion date | August 22, 2019 |
Est. primary completion date | June 22, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women above 18 years of age with biopsy proven, clinically stage 1 or 2 breast cancer who will be undergoing partial mastectomy with SLNBx at Memorial Health Exclusion Criteria: - Women under the age of 18, - Clinically positive axillary nodes - Neoadjuvant therapy for current breast cancer diagnosis - Women with previous SLNBx or axillary node dissection - Pregnant women - Women with previous radiation above the diaphragm, and below the neck |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Health University Medical Center | Savannah | Georgia |
Lead Sponsor | Collaborator |
---|---|
Memorial Health University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of harvested lymph nodes | Looking for differences between the treatment arms in the number of harvest sentinel lymph nodes | 1 day |
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